Safety of aerosol inhalation of recombinant human interferon alpha 2b injection (P. putida) and excipient hydroxyethyl starch 40 to healthy SD rats / 国际儿科学杂志

Objective To investigate the effects of recombinant human interferon alpha 2b injection ( P. putida) and hydroxyethyl starch inhalation on physiological indexes and tissues and organs of SD rats, such as lungs, trachea and bronchus, and thus to explore the safety of the drug and excipients for inhalation. Meth-ods Rats were randomly divided into two groups ( hydroxyethyl starch 40 group and recombinant human inter-feron alpha 2b group). 5 million IU/ml recombinant human interferon alpha 2b injection or 6％ hydroxyethyl starch 40 injection were given respectively, which were diluted with 0. 9％ sodium chloride injection in a radio of 1: 2. Both groups were given aerosol inhalation for 30 minutes once a day for 14 days. Within 14 days after administration, the behavior of rats and the degree of toxicity were continuously observed. During the drug ad-ministration and recovery period, the clinical signs of the rats in each group were observed daily, and the body weight and food consumption were measured once a week. At the end of drug administration and the end of re-covery period, hematology test, blood biochemical test, gross anatomical observation, organ weight determi-nation, and histopathological examination were performed. Results The mass median aerodynamic diameter ( MMAD) of the drug mist was 3. 56 μm, and the geometric standard deviation ( GSD ) was 1. 84 μm, which met the particle size requirements of arrival and deposition in the lower respiratory tract via atomization inhalation. No abnormality in clinical signs, body weight and food consumption, hematology and blood bio-chemical indexes were found in hydroxyethyl starch 40 group and recombinant human interferon alpha 2b group.No abnormal histopathological changes were observed in oral mucosa, tongue, nasal cavity ( paranasal sinus) , larynx, trachea, main bronchial tube, lung, heart, liver, spleen, kidney, reproductive system and other or-gans or tissues examined. Conclusion Results suggest the drug particle size of recombinant human interferon alpha 2b injection (pseudomonas) can reach the lower respiratory tract and deposit in the lower respiratory tract. Continuous atomization inhalation for 14 days has a good safety, and the excipient hydroxyethyl starch 40 has a high safety.

Safety of aerosol inhalation of recombinant human interferon alpha 2b injection(P.putida)and excipient hydroxyethyl starch 40 to healthy SD rats / 国际儿科学杂志

Objective@#To investigate the effects of recombinant human interferon alpha 2b injection(P.putida)and hydroxyethyl starch inhalation on physiological indexes and tissues and organs of SD rats, such as lungs, trachea and bronchus, and thus to explore the safety of the drug and excipients for inhalation.@*Methods@#Rats were randomly divided into two groups(hydroxyethyl starch 40 group and recombinant human interferon alpha 2b group).5 million IU/ml recombinant human interferon alpha 2b injection or 6% hydroxyethyl starch 40 injection were given respectively, which were diluted with 0.9% sodium chloride injection in a radio of 1: 2.Both groups were given aerosol inhalation for 30 minutes once a day for 14 days.Within 14 days after administration, the behavior of rats and the degree of toxicity were continuously observed.During the drug administration and recovery period, the clinical signs of the rats in each group were observed daily, and the body weight and food consumption were measured once a week.At the end of drug administration and the end of recovery period, hematology test, blood biochemical test, gross anatomical observation, organ weight determination, and histopathological examination were performed.@*Results@#The mass median aerodynamic diameter(MMAD)of the drug mist was 3.56 μm, and the geometric standard deviation(GSD)was 1.84 μm, which met the particle size requirements of arrival and deposition in the lower respiratory tract via atomization inhalation.No abnormality in clinical signs, body weight and food consumption, hematology and blood biochemical indexes were found in hydroxyethyl starch 40 group and recombinant human interferon alpha 2b group.No abnormal histopathological changes were observed in oral mucosa, tongue, nasal cavity(paranasal sinus), larynx, trachea, main bronchial tube, lung, heart, liver, spleen, kidney, reproductive system and other organs or tissues examined.@*Conclusion@#Results suggest the drug particle size of recombinant human interferon alpha 2b injection(pseudomonas)can reach the lower respiratory tract and deposit in the lower respiratory tract.Continuous atomization inhalation for 14 days has a good safety, and the excipient hydroxyethyl starch 40 has a high safety.

Topical chemotherapy for giant ocular surface squamous neoplasia of the conjunctiva and cornea: Is surgery necessary?

Purpose: The purpose of this study is to report on the efficacy and safety of topical chemotherapy alone for giant ocular surface squamous neoplasia (OSSN). Methods: In this retrospective, interventional series, 10 eyes with giant OSSN underwent exfoliative biopsy to confirm the diagnosis followed by application of interferon alpha 2b (IFN ?2b) and/or 5 fluorouracil, 1% (5FU). Reported outcome measures were tumor response, visual acuity, recurrence, systemic metastasis, and treatment complications. Results: Ten patients (3 female, 7 male) had a mean age of 73 (median, 69; range 40–89) years. Mean tumor diameter was 13.1 (median, 12.3; range 8.2–19.4) mm. Five (50%) eyes were treated with IFN-?2b alone; 1 (10%) with 5-FU alone and 4 (40%) required both IFN-?2b and 5-FU. The mean duration of treatment was 3, 0.5, and 6.4 months for IFN-?2b alone, 5-FU alone, and both IFN-?2b and 5-FU respectively. Complete tumor response was observed in all 10 cases at mean follow-up of 12.8 (median, 11.5; range, 3–25) months. Complications noted were transient irritation and burning (n = 4), dry eyes (n = 2), and transient flu-like symptoms (n = 2). There was no evidence of chemotherapy-related symblepharon, stem cell deficiency, scleral thinning, or corneal opacity. There were no tumor recurrences, and no patient required surgical excision or cryotherapy. Conclusion: Topical chemotherapy was a safe and effective treatment, inducing complete regression in all cases of giant OSSN in this series. There were no sight-limiting complications.

Stability of Recombinant Human Serum Albumin and Interferon Alpha 2b Fusion Protein for Injection / 中国药学杂志

OBJECTIVE: To explore the stability of recombinant human serum albumin and interferon alpha 2b fusion protein for injection. METHODS: According to the testing methods of Ch.P, influencing factors test [high temperature test at (42±2)℃, strong light test at (4 500±500)lx and humidity test at RH of 90%], accelerated test (37 and 25 ℃)and long-term test were carried out according to the technical guidelines of biological stability study. RESULTS: The results of influencing factors test, accelerated test and long-term test showed that temperature had influence on the purity of products. The protein purity decreased with the increase of temperature. Humidity also had influence on the moisture content of products, with little influence on other indicators. Long term stability investigation found that the sample was relatively stable within 24 months and the examined indexes accorded with the quality standard. CONCLUSION: This recombinant protein can be stored at 2-8 ℃ for 24 months.

Efficacy of nystatin vaginal effervescent tablets and nifuratel tablet combined with recombinant human interferon alpha 2b suppository in the treatment of candida vaginitis / 中国基层医药

Objective To explore the efficacy of nystatin vaginal effervescent tablets , nifuratel tablet combined with recombinant human interferon alpha 2b suppository in the treatment of candida vaginitis .Methods 124 patients with candida vaginitis were selected as the research subjects .The patients were randomly divided into two groups according to different treatment .The control group was treated with nystatin vaginal effervescent tablets +nifuratel tablet,the study group was given recombinant human interferon alpha 2b suppository on the basis of the control group.The symptoms,clinical curative effect,quality of life score,adverse reaction rate were observed and compared in the two groups .Results There were no statistically significant differences between the two groups in symptom and physical signs before treatment (all P>0.05).After treatment,the vulvar itching,burning pain,abnormal leucorrhea,redness symptoms and signs of the study group were (0.95 ±0.44)points,(1.02 ±0.51)points,(1.13 ± 0.62) points,(1.09 ±0.56) points,which were significantly lower than those of the control group [(1.42 ± 0.98)points,(1.28 ±1.02)points,(1.38 ±1.17)points,(1.37 ±1.12)points,t=2.529,2.512,2.505,2.618,all P<0.05].The total effective rate of the study group was 95.2％,which was significantly higher than 74.2％ of the control group (Z=-2.839,P<0.05).After treatment,the quality of life scores of physiological function ,bodily pain,mental health,emotional function and social function in the study group were (80.16 ±9.23)points,(84.22 ± 9.95)points,(87.49 ±10.46) points,(89.27 ±12.35) points,(88.21 ±11.74) points,which were significantly higher than those in the control group[(67.58 ±5.34)points,(71.49 ±7.28)points,(73.52 ±7.61)points,(76.83 ±8.32)points,(75.51 ±8.16) points,t=9.728,8.577,9.036,7.039,7.537,all P<0.05].The incidence rate of adverse reactions of the study group was significantly lower than that of the control group (χ2 =10.978,P<0.05). Conclusion Nystatin vaginal effervescent tablets ,nifuratel tablet combined with recombinant human interferon alpha 2b suppository in the treatment of candida vaginitis can significantly improve clinical symptoms ,improve the therapeutic effect,and improve the quality of life of patients with significant clinical value ,it is worthy of reference .

Effects of IFNα?2b on serum Hepcidin in hepatitis C patients / 实用医学杂志

Objective To investigate the effects of interferon alpha?2b(IFNα?2b)on serum Hepcidin in hepatitis C patients and its mechanism. Methods Hepatitis C patients were divided evenly into treatment group and control group according to whether they had received treatment with IFNα?2b in the past 3 months. The serum hepci?din was compared between the two groups. HepG2 cells and LO2 cells were treated for 24 hours at varied levels of IFNα?2b(0,50,100,200,400μL)and real?time PCR was used to detect the hepcidin,interleukin?6(IL?6)and signal transduction and transcription activator 3(STAT3)mRNA expression of cells. The protein levels of STAT3 and phosphorylated STAT3(pSTAT3)were measured by Western blot. The changes of these indexes were observed with the gradual increase of IFNα?2b levels. Results Serum Hepcidin level in the treatment group was significantly lower than the control(P<0.05). IFNα?2b inhibited the Hepcidin mRNA in HepG2 cells and LO2 cells. pSTAT3 was significantly decreased with the increased levels of IFNα?2b(P<0.05),and the expression of IL?6 and STAT3 had no significant changes with the increase of IFNα?2b. Conclusion The serum Hepcidin levels can be decreased because IFNα?2b suppresses the expression of Hepcidin,and its mechanism may be related with inhibited STAT3 pathway activation.

The efficacy of intravitreal interferon alpha‑2b for the treatment of experimental endotoxin‑induced uveitis

Purpose: To study the efficacy of intravitreal interferon alpha‑2b for endotoxin‑induced uveitis. Materials and Methods: A total of 36 rabbits were randomly allocated to one of the three groups: (1) received interferon plus balanced‑salt solution; (2) received lipopolysaccharide (LPS) plus interferon; and (3) received LPS plus balanced‑salt solution. Intraocular inflammation was evaluated by slit‑lamp biomicroscopy (standardization of uveitis nomenclature grading), binocular indirect ophthalmoscopy (BIO) score, and histopathology. Results: Group 2 showed significantly lower mean (±standard deviation) anterior chamber reaction than Group 3 (3.1 ± 0.9 vs. 3.8 ± 0.4) on day 1 postinjection, lower vitreous cells on days 1 through 7 (day 1: 3.1 ± 0.9 vs. 3.8 ± 0.4; day 3: 2.1 ± 1.6 vs. 3.8 ± 0.4; day 7: 1.9 ± 1.3 vs. 3.6 ± 0.7), and lower BIO score on days 1–7 (day 1: 3.3 ± 1.2 vs. 4.4 ± 0.7; day 3: 3.0 ± 1.4 vs. 4.3 ± 0.9; day 7: 2.4 ± 1.4 vs. 3.7 ± 1.2). The protein content of anterior and vitreous aspirates was lower in Group 2 than 3 (1618.5 ± 411.4 vs. 2567.3 ± 330.8 and 2157.0 ± 283.3 vs. 3204.6 ± 259.5, respectively). Conclusion: Intravitreal interferon alpha‑2b was effective in controlling endotoxin‑induced uveitis.

Clinical Efficacy of Human Interferon Alpha-2b in the Patients with HPV Infection / 中国药师

Objective:To observe the efficacy of human interferon alpha-2b in the patients with HPV infection. Methods:Totally 128 patients with HPV infection were divided into two groups by the random number table with 64 cases in each. The patients in the observation group were treated with human interferon alpha-2b and those in the control group were treated with Baofukang suppositories. The course of treatment was 30 days for two groups. The expression level of HPV E6 / E7 mRNA,p16 and p53 before and after the treatment and the severe adverse reactions in each group were studied. Results:The effective rate of the observation group was 93. 75% ,and that of the control group was 84. 38%(P < 0. 05),the effictive rate of the observation group was better than the control group. After the treatment,the median(M)and the positive expression rate of E6 / E7mRNA,p16 and p53 in the two groups were significantly changed when compared with those before the treatment(P < 0. 05),and the difference between the two groups was also significant(P < 0. 05). After treatment the expression and the positive rate of E6 / E7 mRNA P16 and P53 for different types of diseases in two groups were significanst difference(P < 0. 05),comparisons the parameters between groups were significant difference(P < 0. 05). Conclusion:The clinical efficacy of recombinant human interferon alpha-2b for HPV infection is better and the adverse drug reactions are mild,which can reduce the expression and positive rate of E6 / E7mRNA,p16 and p53 in the patients with HPV infection.

Clinical Evaluation of Recombinant Human Interferon Alpha-2 b Combined with LEEP in the Treatment of Cervical Ectopic Columnar Epithelium with Chronic Cervicitis / 中国药师

Objective:To investigate the clinical efficacy of recombinant human interferon alpha -2b combined with Loop electro-sugical excision procedure( LEEP)in the treatment of cervical ectopic columnar epithelium with chronic cervicitis. Methods:The med-ical records of 68 cases of cervical ectopic columnar epithelium with chronic cervicitis in our hospital from April 2012 to April 2014 treated with LEEP were analyzed retrospectively. The control group(30 cases)was treated with LEEP combined with 5-day postopera-tive oral administration of antibiotics to prevent infection,and the treatment group(38 cases)was given recombinant human interferon alpha -2b through vagina additionally,every other day for 20 days every month after menstrua. After 6 courses of treatment,the clinical efficacy,vaginal bleeding time,vaginal discharge duration,wound healing time and HPV persistent infection were compared between the two groups. Results:The cure rate of the control group was 66. 67%,while that of the treatment group was 92. 11%,and the difference was significant(P<0. 05). Totally 19 cases in the control group were with wound healing(accounted for 63. 33%),while that in the treatment group was 32 cases(accounted for 84. 21%),the difference was significant(P<0. 05). And the vaginal bleeding time,vaginal discharge duration,and wound healing time of the treatment group were all significantly shorter than those of the control group(P<0. 05). After the treatment,the HPV persistent infection rate in the control group was 16. 67%,while that in the treatment group was 0%,and the difference was statistically significant(P<0. 05). The two groups during the treatment process had no obvious adverse reactions,indicating high drug safety. Conclusion:Recombinant human interferon alpha-2b combined with LEEP in the treat-ment of cervical ectopic columnar epithelium is safe and effective,which can effectively shorten the wound healing time,vaginal bleed-ing time and vaginal discharge duration,and is worthy of promotion in clinics.

Interferon-induced depression in patients with hepatitis C: an epidemiologic study / Depressão induzida por interferon em pacientes com hepatite C: um estudo epidemiológico

Objective To assess the incidence rate and severity of depressive symptoms in different time points (12, 24 and 48 weeks) in Brazilian patients with HCV treated with PEG IFN plus ribavirin. Methods We conducted an observational prospective study using the Beck Depression Inventory (BDI) and the Center for Epidemiologic Studies Depression Scale (CES-D). Results Fifty patients were included. The assessments with either scale showed the highest score of depressive symptoms in the 24th week of treatment; the mean BDI score before treatment was 6.5 ± 5.3 and the mean CES-D was 10.9 ± 7.8. After 24 weeks, the mean BDI was 16.1 ± 10.2 and mean CES-D was 18.6 ± 13.0; 46% were diagnosed with depression according to combined BDI and CES-D scores. The somatic/psychomotor subscales were highly correlated with overall scale scores . Subjects with history of substance and alcohol abuse had higher risk for IFN-induced depression. Conclusion Treatment with PEG IFN was associated with a high incidence rate of depressive symptoms in this sample of Brazilian patients, as measured by CES-D and BDI. Alcohol and substance abuse increase the risk of PEG IFN-induced depression. .

Objetivo Avaliar a incidência e a gravidade de sintomas depressivos em diferentes intervalos (12, 24 e 48 semanas) em pacientes brasileiros com HCV tratados com PEG IFN mais ribavirina. Métodos Foi feito um estudo prospectivo observacional, usando o Inventário de Depressão de Beck (BDI) e a Escala de Rastreamento Populacional de Depressão (CES-D). Resultados Foram incluídos 50 pacientes. As avaliações com ambas as escalas mostraram os maiores escores de depressão na 24a semana de tratamento; o escore BDI médio antes do tratamento foi de 6,5 ± 5,3 e o CES-D foi 10,9 ± 7,8. Após 24 semanas, o BDI médio foi 16,1± 10,2 e o CES-D foi 18,6 ± 13,0; de acordo com os escores combinados BDI e CES-D, 46% receberam diagnóstico de depressão. As subescalas somática e psicomotora tiveram alta correlação. Indivíduos com história de abuso de substâncias e de álcool apresentaram maior risco de desenvolver depressão por PEG IFN. Conclusão O tratamento com PEG IFN associou-se a uma alta incidência de sintomas depressivos nessa população de pacientes brasileiros, de acordo com a BDI e CES-D. Abuso de álcool e substâncias aumentam o risco de depressão induzida por PEG IFN. .

Practice of Clinical Pharmacists in the Treatment of One Case of Cervical Malignant Melanoma / 中国药师

Objective:To investigate the participation of clinical pharmacists in the drug treatment regimen and the methods of pharmaceutical care. Methods:Clinical pharmacists participated in the treatment of one case of cervical malignant melanoma and pro-vided the comprehensive pharmaceutical care, including making the individualized anti-tumor treatment plan, calculating the dose, mo-nitoring the adverse drug reactions. Results: The therapeutic schedule suggested by clinical pharmacists was adopted to improve the clinical outcomes and reduce the adverse reactions. Conclusion: The participation of clinical pharmacists in the practice of clinical drug therapy can improve the level of drug therapy.

Efeitos colaterais do tratamento da hepatite C no polo aplicador do ABC / Side effects of the hepatitis C treatment at the ABC application center

OBJETIVO: Analisar e comparar os efeitos colaterais do tratamento da hepatite C com interferon peguilado e ribavirina no Centro de Referência de Imunobiológicos Especiais (CRIE) do Hospital Mário Covas (Santo André), de 23/02/2011 a 05/05/2011. MÉTODOS: Estudo do tipo transversal, por questionário, com amostra não probabilística composta por 340 pacientes que receberam pelo menos uma dose da medicação. RESULTADOS: Os efeitos colaterais apresentados foram cansaço (82,9%), artralgia e/ou mialgia (76,8%), emagrecimento (71,8%), cefaleia (67,6%), desânimo (65,9%), depressão e/ou irritabilidade (64,4%), prurido (60,6%), febre (59,1%), alopecia (51,5%), tosse seca (34,1%), náuseas (11,7%), inapetência (11,7%) e tontura (7,9%). Foram relatados até 19 sintomas durante o tratamento. Apenas quatro pacientes (1,2%) não apresentaram efeitos colaterais. Ao comparar os interferons, observamos que o uso do alfa-2b causou uma média de 8,01 sintomas por paciente, enquanto o do alfa-2a foi responsável por uma média de 7,50. Os pacientes em uso do interferon alfa-2b apresentaram mais febre, emagrecimento, cefaleia, artralgia e/ou mialgia, cansaço, desânimo, depressão e/ou irritabilidade e tosse seca do que os pacientes em uso do alfa-2a, que, por sua vez, tiveram mais alopecia e prurido. CONCLUSÃO: O estudo mostra uma grande morbidade relacionada ao tratamento, já que apenas 1,2% dos pacientes não apresentaram efeitos colaterais. Na amostra, o interferon peguilado alfa-2b foi responsável por maior prevalência de febre e emagrecimento quando comparado ao alfa-2a, sendo essa relação estatisticamente significante (p < 0,05).

OBJECTIVE: To review and compare side effects of hepatitis C treatment with pegylated interferon and ribavirin at the CRIE of the Hospital Mário Covas (Santo André), São Paulo, Brazil, from February 23 to May 5, 2011. METHODS: Cross-sectional study through questionnaire, with a non-probability sample comprised of 340 patients that had received at least one dose of the medication. RESULTS: Side effects presented were fatigue (82.9%), arthralgia and/or myalgia (76.8%), weight loss (71.8%), headache (67.6%), listlessness (65.9%), depression and/or irritability (64.4%), itching (60.6%), fever (59.1%), alopecia (51.5%), dry cough (34.1%), nausea (11.7%), inappetence (11.7%), and dizziness (7.9%). Up to 19 symptoms were reported during treatment. Only four patients (1.2%) did not present side effects. When comparing the types of interferon, it was observed that alpha-2b caused an average of 8.01 symptoms per patient, while alpha-2a was responsible for an average of 7.50 symptoms. Patients using interferon alpha-2b showed more fever, weight loss, headache, arthralgia and/or myalgia, fatigue, listlessness, depression and/or irritability, and dry cough than patients using alpha-2a, who had more alopecia and itching. CONCLUSION: The study shows a high morbidity related to the treatment, as only 1.2% of the patients showed no side effects. In the sample, the pegylated interferon alpha-2b was responsible for higher prevalence of fever and weight loss when compared to alpha-2a, and this was a statistically significant relation (p < 0.05).

Quimioprofilaxis en la recidiva tumoral vesical / Chemoprophylaxis in the vesical tumoral recurrence

Los tumores vesicales superficiales se caracterizan por una alta tasa de recidiva, que ocurre especialmente dentro de los dos primeros años, y que es aun mayor en los grupos de alto riesgo. Existe consenso en la utilidad del uso del Bacilo de Calmette-Guerin para disminuir la recurrencia tumoral. La quimioterapia intravesical con otros medicamentos han demostrado su utilidad o no en disminuir la recurrencia de estos tumores vesicales. Entre los años 1999 y 2008 se estudian y tratan 110 pacientes (96 hombres y 14 mujeres), con una edad promedio de 63 años, divididos en tres grupos para tratamiento de la recidiva tumoral después de resección transuretral o cistectomía parcial, con tres diferentes agentes quimioprofilácticos e inmunomoduladores (Thio-Tepa, BCG+factor de transferencia, doxorrubicina+interferón alfa 2b). El objetivo de esta investigación fue presentar la experiencia en el tratamiento de estos pacientes, donde se observa mejores resultados en 5 años, con el grupo tratado con doxorrubicina+interferón alfa 2b, seguido del grupo tratado con BCG+factor de transferencia, con una marcada disminución de las recurrencias y una limitación en la progresión de la enfermedad a largo plazo.

The superficial bladder tumors are characterized by a high rate of recurrence taking place especially within the first two years that is even higher in the high risk groups. There is an agreement in the usefulness of the Calmette-Guerin Bacillus (CGB) to diminish the tumoral recurrence. The intravesical chemotherapy with other medications have demonstrated its profit or not in decreasing the recurrence of these bladder tumors. Between 1999 and 2008 we studied and treated 110 patients (96 men and 14 women), aged in average 63 years old. They were divided into three groups for the treatment of the tumoral recidivism after the transurethral resection or partial cystectomy, using three different chemoprophylactic agents and inmunomodulators (Thio-Tepa, BCG+Transference Factor, Doxorubicin +Interferon Alpha 2b). The objective of this research was presenting our experience in the treatment of these patients during five years, obtaining better results in the group treated with doxorubicin + interferon alpha 2b, followed by the group treated by means of BCG + transference factor, with a remarked decrease of the recurrence and a limitation in the long term progression of the disease.

A reduced dose of ribavirin does not influence the virologic response during pegylated interferon alpha-2b and ribavirin combination therapy in patients with genotype 1 chronic hepatitis C

BACKGROUND/AIMS: When combined with pegylated interferon alpha-2b (Peg-IFN alpha-2b) for the treatment of genotype 1 chronic hepatitis C (CHC) in Korea, the current guideline for the initial ribavirin (RBV) dose is based on body weight. However, since the mean body weight is lower for Korean patients than for patients in Western countries, current guidelines might result in Korean patients being overdosed with RBV. METHODS: We retrospectively reviewed the medical records of patients with genotype 1 CHC who were treated with Peg-IFN alpha-2b and RBV combination therapy. We divided the patients into groups A (> or =15 mg/kg/day, n=23) and B (<15 mg/kg/day, n=26), given that the standard dose is 15 mg/kg/day. The clinical course in terms of the virologic response, adverse events, and dose modification rate was compared between the two groups after therapy completion. RESULTS: The early response rates (92.0% vs. 83.3%, P=0.634) and sustained virologic response rates (82.6% vs. 73.1%, P=0.506) did not differ significantly between the two groups. During the treatment period, the RBV dose reduction rate was significantly higher in group A than in group B (60.9% vs. 23.1%, P=0.01). CONCLUSIONS: RBV dose reduction is performed frequently when patients are treated according to the current Korean guidelines. Given that lowering the RBV dose did not appear to decrease the virologic response during therapy, reducing RBV doses below the current Korean guideline may be effective for treatment, especially in low-weight patients.

Seguridad de la terapia de interferón alfa 2b recombinante más ribavirina en la hepatitis crónica C / Safety of recombinant interferon alpha 2b plus ribavirin in chronic hepatitis C

La hepatitis crónica C ha adquirido rango de pandemia. El virus de la hepatitis C se ha convertido en la causa principal de hepatitis crónica, cirrosis hepática, hepatocarcinoma, y trasplante de hígado a nivel mundial. OBJETIVO: identificar los efectos adversos asociados a la terapia combinada interferón alfa 2b recombinante más ribavirina durante la evolución del tratamiento y hasta 8 semanas después de finalizado, así como los principales efectos asociados a salidas temporales o definitivas de esta terapia. MÉTODOS: estudio de farmacovigilancia cuya serie estuvo conformada por 122 pacientes con hepatitis crónica C atendidos en el Instituto de Gastroenterología desde mayo de 2001 hasta mayo de 2006. Se utilizó interferón alfa 2b recombinante (3 millones de unidades 3 veces por semana) más ribavirina (1 000 o 1 200 mg diarios en dependencia del peso corporal) durante 48 semanas. RESULTADOS: el 88,5 por ciento del total de casos presentó efectos adversos; de ellos el 79,5 por ciento correspondió al síndrome seudogripal, seguido de manifestaciones hematológicas, neuropsiquiátricas, gastrointestinales, entre otras menos frecuentes. El 6,6 por ciento de la serie presentó salidas temporales del tratamiento por efecto adverso distinto de la anemia y 4 pacientes, salidas definitivas del estudio, tres por anemia hemolítica severa y uno con hipertiroidismo no controlable. CONCLUSIONES: la terapia combinada interferón alfa 2b recombinante más ribavirina resulta segura, donde el mayor número de casos presentó síndrome seudogripal como efecto adverso más frecuente. Las manifestaciones hematológicas asociadas a las salidas definitivas del estudio permitieron recomendar seguimiento estricto de la hemoglobina y profundizar en el diagnóstico y tratamiento de los principales efectos adversos presentes en otros sistemas y asociados a esta terapia

Chronic hepatitis C has reached the category of pandemic. The hepatitis C virus is the main cause of chronic hepatitis, hepatic cirrhosis, hepatocarcinoma and liver transplantation worldwide. OBJECTIVE: to identify the side effects of a combined therapy of recombinant interpheron alpha 2b plus ribavirin during the treatment and up to 8 weeks afterwards, as well as the main effects related to temporary or definitive withdrawal. METHODS: a pharmacological surveillance study was performed in which 122 patients with chronic hepatitis C, who had been seen at the Institute of Gastroenterology from May 2001 to May 2006, were included. Recombinant interferon alpha 2b (3 million units administered 3 times a week) plus ribavirin (1 000 or 1 200 mg daily depending on the body weight) was the therapy used for 48 weeks. RESULTS: of the total number of cases, 88,5 percent had side effects; 79,5 percent of which corresponded to pseudocold syndrome followed by hematological, neuropsychiatric and gastrointestinal manifestations, and other less frequent ailments. In the studied group, 6,6 percent had to interrupt their treatment temporarily due to some side effect different from anemia whereas 4 patients gave up the study, three affected by severe hemolytic anemia and one with uncontrollable hyperthyroidism. CONCLUSIONS: the combined therapy of recombinant interferon alpha 2b plus ribavirin proved to be safe; the most frequent side effect was pseudocold syndrome in the majority of cases. The hematological manifestations that made the patients to give up the study led to recommend a strict follow-up of hemoglobin levels and thorough diagnosis and treatment of the main side effects found in other systems and associated to this combined therapy

Vogt-Koyanagi-Harada disease occurring during pegylated interferon-alpha2b and ribavirin combination therapy for chronic hepatitis C / 대한간학회지

Vogt-Koyanagi-Harada (VKH) disease is a multisystem syndrome characterized by ocular (uveitis and retinal detachment), neurological (headache, tinnitus, and meningitis), and integumentary (vitiligo, alopecia, and poliosis) involvement. Although the pathogenesis of VKH disease is not well understood, an autoimmune T-cell response to a melanocyte-associated antigen is considered to be a cause of VKH disease. The complex immunological response to interferon and ribavirin may induce or exacerbate the autoimmune condition; however, VKH disease is a very rare complication associated with interferon therapy in chronic hepatitis C. We report a case of VKH disease occurring during pegylated interferon-alpha2b and ribavirin combination therapy for chronic hepatitis C.

Generalized Eczema-like Eruption in a Patient Treated with Interferon Alpha-2b and Ribavirin for Chronic Hepatitis C / 대한피부과학회지

The combination of interferon alpha with ribavirin is currently recommended in the treatment of hepatitis C virus (HCV) infection. Commonly reported cutaneous reactions include localized reactions such as injection site inflammation and necrosis and worsening of other skin disorders, including psoriasis, lichen planus, vitiligo, or systemic lupus erythematosus. However, generalized eczematous reactions have been reported to occur uncommonly in patients treated with interferon and ribavirin, however such a case has not been described in the Korean literature. Herein, we describe a 49-year old female showing generalized eczema-like eruption after treatment of interferon alpha-2b and ribavirin for chronic HCV infection.

A Case of Idiopathic Hypereosinophilic Syndrome Treated Successfully with Hydroxyurea and Interferon alpha-2b / 대한소아혈액종양학회지

The idiopathic hypereosinophilic syndromes are rare hematologic disorders showing a wide spectrum of diseases with eosinophilia and associated organ damage. Three criteria for diagnosis include persistent eosinophilia of at least 1, 500 eosinophils/mm3 for longer than 6 months, or death before 6 months with signs and symptoms of hypereosinophilic disease; lack of evidence for parasitic, allergic or other known causes of eosinophilia; and signs and symptoms of organ involvement. We report a case of a 8 month-old male patient who had persistent marked eosinophilia reaching peak eosinophil count more than 100, 000/mm3, and organ dysfunction involving the bone marrow, heart, brain, lung and spleen. This patient, who did not respond to administration of prednisolone or hydroxyurea alone, has been treated successfully with hydroxyurea and interferon alpha-2b combination therapy.

A Case of Kaposiform Hemangio-Lymphangiomatosis / 대한소아혈액종양학회지

Kaposiform hemangio-lymphangiomatosis is an extremely rare and locally aggressive vascular neoplasm. This neoplasm histologically shows dilated vascular spaces lined by flat endothelium-like cells and areas of spindle cells forming slit-like vascular spaces similar to those described in Kaposi's sarcoma. We report a case of this neoplasm which originated from the mediastinum infiltrating other adjacent soft tissues such as thymus and pulmonary interstitium without the evidence of distant metastasis. In spite of interferon-alpha2b therapy and excision of this neoplasm, the patient expired due to respiratory failure caused by aggravating interstitial pneumonia and progression of the neoplasm.